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Sitagliptin phosphate/metformin hydrochloride FDC
Sitagliptin phosphate/metformin hydrochloride FDC is a DPP-4 inhibitor / biguanide combination Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently FDA-approved for Type 2 diabetes mellitus. Also known as: Janumet®.
This combination drug inhibits dipeptidyl peptidase-4 (DPP-4) to increase incretin levels while metformin reduces hepatic glucose production and improves insulin sensitivity.
This combination drug inhibits dipeptidyl peptidase-4 (DPP-4) to increase incretin levels while metformin reduces hepatic glucose production and improves insulin sensitivity. Used for Type 2 diabetes mellitus.
At a glance
| Generic name | Sitagliptin phosphate/metformin hydrochloride FDC |
|---|---|
| Also known as | Janumet® |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | DPP-4 inhibitor / biguanide combination |
| Target | DPP-4 enzyme / metformin (AMPK pathway) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Sitagliptin is a DPP-4 inhibitor that prevents the breakdown of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby increasing insulin secretion in response to meals and reducing glucagon secretion. Metformin is a biguanide that decreases hepatic glucose production and improves peripheral insulin sensitivity. Together, they provide complementary glucose-lowering effects in type 2 diabetes.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Gastrointestinal disturbances (nausea, diarrhea, abdominal pain)
- Headache
- Upper respiratory tract infection
- Nasopharyngitis
Key clinical trials
- Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes (PHASE4)
- Glimepiride, Empagliflozin, and Sitagliptin With Metformin for Type 2 Diabetes (PHASE4)
- Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. (PHASE1)
- Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions. (PHASE1)
- Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. (PHASE1)
- Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions. (PHASE1)
- Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed) (PHASE1)
- A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sitagliptin phosphate/metformin hydrochloride FDC CI brief — competitive landscape report
- Sitagliptin phosphate/metformin hydrochloride FDC updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Sitagliptin phosphate/metformin hydrochloride FDC
What is Sitagliptin phosphate/metformin hydrochloride FDC?
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Related
- Drug class: All DPP-4 inhibitor / biguanide combination drugs
- Target: All drugs targeting DPP-4 enzyme / metformin (AMPK pathway)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Also known as: Janumet®
- Compare: Sitagliptin phosphate/metformin hydrochloride FDC vs similar drugs
- Pricing: Sitagliptin phosphate/metformin hydrochloride FDC cost, discount & access